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Effectiveness of Digital Intervention (HM4MH-app) on Perinatal Psychological Wellbeing

NCT06862193 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2025-12-22

No results posted yet for this study

Summary

As many as 25% of pregnant women report mental health problems such as depressiveness and anxiety. This is a major concern as mental illness during pregnancy can have severe and long-lasting consequences for the pregnant woman, the baby, as well as the partner. Digital interventions (e.g., apps) have shown to be promising in promoting mental wellbeing, at scale, however, the majority of tools have been developed and evaluated in a general population rather than tailored for pregnancy. The objective of this trial is to investigate the effectiveness of a new digital tool (HealthyMoms4MentalHealth-app) on mental health outcomes during the perinatal period.

Conditions

  • Mobile Application
  • Behavior
  • Perinatal Mental Health

Interventions

BEHAVIORAL

HealthyMoms4MentalHealth

The intervention is a mobile application targeting women during the perinatal period, aiming to promote mental wellbeing.

BEHAVIORAL

HealthyMoms

Digital intervention focusing on lifestyle behaviours during the perinatal period.

Sponsors & Collaborators

Principal Investigators

  • Kristin Associate Professor Thomas, PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-10
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06862193 on ClinicalTrials.gov